Steel 88862226-69Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521102385), received between May 23, 2017 and Aug 22, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SURGEON NOTICED THAT THE STEEL WIRES WERE BREAKING WHILE THE WIRE WAS BEING TIGHTENED. IT WAS ALSO NOTED THAT THE WIRE APPEARED TO BE MORE FRAGILE IN THE CRIMPING AREA.

  Patient problems: Insufficient Information

  MAUDE report 17600351 ↗
• MalfunctionAug 21, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN ANTERIOR INTERVENTRICULAR CORONARY ARTERY BYPASS GRAFTING, THE SURGEON NOTICED THAT THE STEEL WIRES WERE BREAKING WHILE THE WIRE WAS BEING TIGHTENED. IT WAS ALSO NOTED THAT THE WIRE APPEARED TO BE MORE FRAGILE IN THE CRIMPING AREA. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17587271 ↗
• MalfunctionNov 1, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC AORTIC VALVE REPLACEMENT, WHEN CLOSING THE STERNUM, THE PASSAGE WAS DIFFICULT, AND THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729708 ↗
• MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MITRAL VALVE REPAIR, AT STERNOTOMY CLOSURE, THE NEEDLE LOOSENED FROM THE THREAD. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE REPORTED CONDITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8753345 ↗
• InjuryMay 14, 2019Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, AT THE TIME OF CLOSURE DURING THE EXPLORATORY STERNOTOMY, THE NEEDLE USED APPEARED FRAGILE FROM THE FIRST TRANSOSSEOUS PASSAGE. THE SUTURED DULLED AND TWISTED UNTIL IT BECAME STRAIGHT AND DISENGAGED FROM THE STEEL WIRE. IN ADDITION, STEEL WIRE WAS DIFFICULT TO TIGHTEN AT THE BONE EDGES BECAUSE IT BROKE. A FOREIGN BODY WAS IN THE SURGICAL SITE. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE AND INCISION WAS EXTENDED TO MORE THAN 1 INCH. THE EXTENSION OF THE SURGICAL TIME WEAKENED THE STERNAL BONE.

  Patient problems: No Code Available

  MAUDE report 8609478 ↗
• MalfunctionMay 6, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING STERNUM CLOSURE, AT THE END OF THE PROCEDURE, WHEN THE STERNUM WAS CLOSED AND THE STEEL WIRES WERE LAID, 3 OUT OF 6 NEEDLES BROKE AND HAD TO BE REMOVED TO INSTALL NEW ONES. THE NEEDLE AND THREAD DISENGAGED WHEN PASSING THROUGH THE STERNUM. THE DEVICE REPLACED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8584911 ↗
• MalfunctionApr 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN TRYING TO CLOSE THE STERNUM ON AN OPEN PROCEDURE, THE STEEL WIRES WERE DISLODGED. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8537194 ↗
• InjuryMar 21, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN CLOSING THE SURGICAL SITE, THE WIRE OF THE STEEL LOOSENED AS PASSING THE STERNUM. THE PROBLEM COMPLICATES THE CLOSURE AND REQUIRES ADDITIONAL HEMOSTASIS OF THE STERNUM. THE CLOSURE TIME WAS LENGTHENED.

  Patient problems: Hemostasis; No Code Available

  MAUDE report 8439913 ↗
• MalfunctionFeb 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE "STERNOMOTY", ON THE INTRODUCTION OF THE NEEDLE INTO THE TISSUES, THE NEEDLE BROKE. THERE WERE MORE THAN ONE DEFECTIVE DEVICE INVOLVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7299242 ↗
• MalfunctionMay 23, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE NEEDLE BREAKS OFF DURING USAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6584766 ↗